510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810337Substantially Equivalent

Pdi Surgical Scrub Sponge-Brush-T15070

Nice-Pak Products, LLC, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810337 is the FDA 510(k) clearance record for PDI SURGICAL SCRUB SPONGE-BRUSH-T15070, a class I device, cleared for Nice-Pak Products, Inc. on under FDA product code GEC (Brush, Scrub, Operating-Room). FDA records list 9 510(k) clearances for Nice-Pak Products, Inc., from to . As of , FDA records show no recalls naming K810337.

Clearance record

Decision date
Received
(17 days to decision)
Product code
GEC Brush, Scrub, Operating-Room
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Nice-Pak Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GEC

Trailing 12 months

FDA records hold no clearances under product code GEC in the trailing twelve months.

FDA records show no clearances under product code GEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260